MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Use of Device Problem (1670)

Patient Problems Low Blood Pressure/ Hypotension (1914); Sepsis (2067)

Event Date 01/28/2021

Event Type  Death  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, 3 hours into the case, the oxygenator started to fail.The patient presented pre-operatively extremely hypotensive and acidotic and neurologically confused.Pre-operative blood gases were indicative of her septic and hypotensive state, often referred to as vasoplegia.The patient received two rounds of cyanokit treatment.The first dose was given pre-operatively and then a second dose was given on bypass.The patient had unstable blood pressure maintenance and the intractable acidosis.The ph level at its zenith on bypass was 7.2.Bicarbonate or buffer levels were reported to be as high as 180.At approximately 2.5 to 3 hours on bypass the co2 levels with 10l of sweep gas was 58 mmhg.The po2 was 104 mmhg.The initial avr procedure was completed.A second oxygenator was added to augment the ability to remove co2 at an accelerated rate to replace the mitral valve.The anerobic metabolism occurring was being supported by the ongoing struggle to control hypotension.This prompted the second round of cyanokit being used while on cpb.With the second oxygenator being installed in a series configuration, blood gas control was improved significantly.Unfortunately, even with the improvements in gas exchange the patients acid base status never normalized.The mitral valve replacement was completed.The patient was placed on v-a ecmo for transfer to the cvicu where the patient succumbed.The product was not changed out.The surgery was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on feb 22, 2021.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions:4315 - cause not established.The actual sample was not returned for investigation; therefore, a through investigation could not be performed and a root cause could not be determined.The raw material performance test results were reviewed and confirmed to meet the factory's specification and no anomaly was found.Review of the manufacturing record and incoming inspection record of the involved product/lot # combination confirmed there was no anomaly.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information was received indicating that the patient complains vomiting, abdominal pain which was resolved on presentation to the er, encephalopathy, thrombocytopenia, ttp, gram + bacteremia, metabolic acidosis.

• Brand Name: STERILE FX25RWC W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 11361522
• MDR Text Key: 232933514
• Report Number: 1124841-2021-00024
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: XN04
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 32 YR
• Patient Weight: 97